Kornimate/medical-research-clean huggingface dataset:
diet and prevention of ischemic heart disease: a translational approach

Conditions: Ischemic Heart Disease

Summary: the objective of this study is to test the effect of substitution dietary guidelines that are specifically aimed at the prevention of ischemic heart disease (ihd) on the dietary intake in the general danish population.

225 participants will be included in the intervention. the intervention is planned to run for six months in a real life setting. the study is a randomized, parallel dietary intervention study. dietary intake, selected ihd biomarkers and anthropometric measurements will be measured at two visits during the intervention period as well as 6 months after the end of the intervention. the study includes a baseline visit followed by a visit where web based dietary records will be completed by the subjects and blood samples and anthropometrics will be measured. the intervention will consist of information on dietary advice due to the specific ihd dietary guideline or the current national dietary guidelines. the information will be provided to the participants via leaflets and recipes. after the baseline visit the subjects will be randomized to group a, b or c: in group a the subjects will receive dietary advice, according to the specific ihd dietary guideline, in group b the subjects will receive dietary advice according to the current national dietary guidelines and in group c the subjects will be instructed to follow their normal dietary habits.

Eligibility criteria:
inclusion criteria: * healthy men and women aged 30 to 65 years who has one or more self-assessed ischemic heart disease risk factors at screening: physical inactivity, overweight or obese (bmi ≥ 25/m2 ), waist circumference (≥ 80 cm for women, ≥ 94 cm for men). in addition, the participants should have the motivation and willingness to be randomized to any of the three groups, and to do their best to follow the given protocol . exclusion criteria: * no internet access or no access to a computer, smoking, pregnancy, or breast-feeding or planning to become pregnant within the next 12 months, a history of cardiovascular disease, type 2 diabetes, chronic disease / disorders that may affect the results of the study, substance abuse within the past 12 months, regular alcohol consumption \> 21 units / week for men or \> 14 units/ week for women, allergy or intolerance to food groups in the dietary guidelines, supplements with mega doses of nutrients that can have potential impact on ischemic heart disease risk markers (eg . fish oils).

Keywords: ischemic heart disease, dietary guidelines
prevention among young people with intellectual disability

Conditions: Intellectual Disability; Adolescent Development; Young Adult

Summary: this study aims to evaluate an intervention using the toolkit "children - what does it involve?" and the "real-care-baby" (rcb) simulator among students with intellectual disability (id), using a cluster randomized trial design with waiting-list control group.

background: there is limited knowledge about how young people with id can be facilitated in their process of deciding about parenthood. a feasibility study showed that it is possible to evaluate an intervention using the chosen instruments among students with id in order to provide them with further insights about parenthood. methods: randomization of eleven clusters/schools to intervention and eleven clusters to waiting-list control. intervention includes thirteen educational lessons and a three-day and night caring-session with the rcb simulator. intervention will be given 1-2 lessons/week during 8-14 weeks. data will be collected with questionnaires and interviews before and after intervention. in control group: before and after waiting-list time and after intervention.

Eligibility criteria:
inclusion criteria: * students with mild or moderate id with informed consent can be included * understand and respond to a questionnaire exclusion criteria: - students with severe id

Keywords: intellectual disability parenthood reproduction intervention adolescents
reliability of all on 4 using 2 zygomatic and 2 conventional implants vs all on 4 implants for rehabilitation of maxilla

Conditions: Edentulous; Alveolar Process, Atrophy

Summary: oral rehabilitation by dental implants in the severely atrophic maxilla often represents a challenge. to overcome this difficulty, bone augmentation procedures such as sinus augmentation, guided bone regeneration (gbr), or distraction osteogenesis have been used to obtain adequate bone height and width for proper three-dimensional implant placement. to avoid surgical morbidity and shorten treatment length, alternative methods such as short or tilted implants, as well as zygomatic implants (zis),have been proposed and have shown promising outcomes.

placement of dental implants in the pterygo-maxillary region provides adequate posterior bone support for the prosthesis which permits better distribution of masticatory forces without the need of sinus floor augmentation, onlay and inlay grafts, split crest technique, or osteogenic distraction. this allows rehabilitating patients with satisfactory full arch fixed maxillary prosthesis, which is usually spanned from second molar to contralateral second molar tooth. the purpose of the present study is to compare the reliability of all on four by 2 zygomatic implants with 2 conventional implant in anterior region versus all on four approach by conventional implant for the rehabilitation of the atrophied maxilla in terms of survival rates and improving the quality of patient's life and involved complication with maxillary sinus.

Eligibility criteria:
inclusion criteria: 1. patients with severely atrophic edentulous upper arch (cawood class iv, v, vi) that could not be restored with other type of treatment. 2. patients who had at least 8-12 mm vertical bone height in anterior maxilla to allow installation of at least 2 conventional implants. exclusion criteria: 1. patients with any systemic disease that might interfere with dental implants placement and/or osseointegration e.g. uncontrolled diabetes, hypertension and osteoporosis, etc. 2. heavy smoker (\> 20 cigarettes daily) and patients with history para-functional habits (e.g. clenching or bruxism, etc.) were also excluded. 3. intraoral pathological lesion, related to maxilla, maxillary sinus and zygoma.

Keywords: all on four zygomatic implant
gastrodia and uncaria recipe in treating stage-one hypertension: an evidence-based optimization study

Conditions: Hypertension

Summary: gastrodia and uncaria recipe is a well-known effective prescription in traditional chinese medicine (tcm) to treat hypertension of liver yang hyperactivity type, which manifests symptom of headache or dizziness. however, it lacks consolidated evidence by multi-center randomized controlled trials. the hypothesis of this study is that gastrodia and uncaria granule may have significant anti-hypertensive effect on patients with stage-one hypertension and liver-yang hyperactivity syndrome than placebo. this study is a randomized, controlled, multi-center, double-blind clinical trial. this study aims to recruit 500 hypertension patients who 1) are untreated or taking anti-hypertensive medicine for at least two weeks and 2) have an office systolic blood pressure of 140-159 mmhg, an office diastolic blood pressure of \ =130 mmhg. the patients will be stratified according to center, sex, and the tcm type of liver yang hyperactivity/ liver yang non-hyperactivity, and are then randomly assigned to the treatment of gastrodia and uncaria granules or placebo for 2 months. the blood pressure lowering effect is evaluated by 24-hour ambulatory systolic blood pressure (primary outcome) / diastolic blood pressure, as well as by home and office blood pressures.


Eligibility criteria:
inclusion criteria: 1. male and female sex, aged 18-80 years. 2. not taking anti-hypertensive drugs for at least two weeks, or taking anti-hypertensive drugs for more than two weeks. 3. office blood pressure averages of three consecutive readings per visit, at two screening visits all meet the limits: systolic blood pressure ranges from 140 to 159 mmhg, and diastolic blood pressure \<100 mmhg. 4. 24h ambulatory mean systolic blood pressure \>= 130mmhg. 5. agreed to participant, able to join follow-up and to come to hospital at each visit. 6. signed informed consent. exclusion criteria: 1. secondary hypertension, confirmed or suspected. 2. failed at ambulatory blood pressure monitoring: effective reading \< 70%, or the number of awakening bp reading \<20, or sleep time bp reading \<7. 3. taking drugs that must be used for other diseases but have a potential effect on blood pressure, such as males taking alpha blockers for prostatic hypertrophy. 4. having the onset of cardiovascular and cerebrovascular diseases such as stroke, myocardial infarction or heart failure within 6 months. 5. having a history of atrial fibrillation or frequent arrhythmia. 6. having abnormal lab test results: liver function (alt, ast, tbl) ≥ 2 times the upper normal limit, or serum creatinine ≥ 176umol/l, or serum potassium ≥ 5.5mmol/l. 7. pregnant or breastfeeding (for females). 8. complicating other diseases that are not suitable for the trial, such as thyroid disease with active medication, acute infectious diseases, chronic mental illness, and tumors. 9. possible poor compliance with the research process.

Keywords: gastrodia and uncaria stage one hypertension liver yang hyperactivity
the impact of nasogastric indwelling versus oral intermittent tube feeding methods on premature infants

Conditions: Premature Infants

Summary: this clinical pilot trial is being conducted to learn more about the infant's feeding behavior while being fed by indwelling nasogastric tube placement or by intermittent oral tube placement. healthy preterm infants who are transitioning from gavage to oral feedings via oral intermittent tube insertion may achieve full oral feeds by bottle/breast at an earlier gestational age than infants feeding with indwelling tubes and may be ready for earlier discharge.

independent feeding is often one of the last competencies that the premature infant must accomplish prior to discharge from hospital. feeding is a complex task for the premature infant to accomplish and it often takes many weeks for the infant to learn how to feed. therefore, tube feeding is required for the infant to ingest adequate nutrition during the transition from gavage feeding to oral feeding. both intermittent oral gavage tube placement and indwelling nasogastric tube placement are acceptable methods for feeding preterm infants. however, it is not known which tube feeding method will support an expedited transition to oral feeding. the choice of using one method over the other is currently based on the individual health care provider's opinion or historical institutional practices and insufficient evidence is available to guide tube feeding practices.

Eligibility criteria:
inclusion criteria: * premature infants born between 30-33 and 6/7th weeks gestation are an appropriate size for gestational age, are not on oxygen are of any race, sex and require tube feeding and are less than 34 and 3/7th weeks gestation. exclusion criteria: * infants with neurological abnormalities or insults, ivh greater than a grade of two, pvl, birth asphyxia, seizures, cord has less than 7.0 ph, chest compressions, infants who require abstinence scoring, infants with major congenital anomalies or major genetic anomalies that impact feeding ability such as diaphragmatic hernia and cleft palate, major cardiac defects, infants who develop necrotizing enterocolitis, infants who received more than 14 days of intubation or cpap or oxygen by nasal prongs and infants of diabetic or alcoholic mothers.

Keywords: tube feeding premature infant
maternal-foetal transmission of sars-cov-2

Conditions: Maternal Fetal Infection Transmission; COVID-19; SARS-CoV 2

Summary: one case of maternal-fetal transmission of sars cov-2 was published (1). ig m and ig g were found at two hours after birth of a new born from a mother covid-19. another study on few newborns covid-19 reported that the sars-cov-2 was not transmitted in utero but only after birth. although there are few data on covid-19 during pregnancy, according to our national data collections, it appears to be responsible for miscarriages and fetal deaths. there are also intrauterine growth restrictions and an increase of the rate of cesarean sections for maternal indications. therefore, it is essential to know if there is a maternal viremia which infects the fetus because the consequences in terms of management would be completely different. in fact, the potential intrauterine infection will lead to antenatal monitoring of these patients with an antenatal diagnosis and may be a treatment. therefore, it seems essential to explore the mode of transmission to the newborn since many newborns have covid-19 infection the investigators will propose to all pregnant women sars- cov-2 positive to perform pcr sars-cov-2 tests and /or serology's (igm and ig g) on the amniotic fluid, the blood cord and the placenta.

pregnant women sars cov-2 positives during pregnancy or during labor tested by a rt-pcr sars-cov-2 on nasopharyngeal swabs and/or by serologies. after informed consent the ivestigators will proceed during labor to: 1. a vaginal swab of amniotic fluid during the rupture of the water pocket during labor. 2. a blood sample from the umbilical cord after delivery of the newborn and clamping and sectioning of the cord. pcr covid-19 and serologies (ig m and ig g) as well as investigating viral proteome and cytokines. these are additional samples in addition to the routine samples which have no impact and without risk for the mother the newborn since they are taken after delivery from the side of the placenta after clamping and sectioning of the cord. 3. samples of 2 fragments of placenta after delivery of the placenta for covid-19 research, which usually goes to waste or to pathology depending on the clinical context or for infectious tests. in all cases, samples of 3 to 4 cm3 will be taken which will in no way interfere with current analyzes carried out on the placenta which weighs one third of the fetal weight on average. a viral search by covid-19 pcr will be carried out on the placenta fragment and another part will be frozen for analysis by electron microscopy and study of the viral proteome, cytokines and immune mechanisms. placenta samples will be frozen at -80 degrees.

Eligibility criteria:
inclusion criteria: * all pregnant women sars-cov-2 positive during the pregnancy * informed consent obtained * 18 years to 48 years exclusion criteria: * pregnant women without sars-cov-2 infection ( pcr test and or serologies negatives) * curatorship patients. * refusal to participate to the study

Keywords: pregnancy rt-pcr-covid-19 sars-cov 2 serologies placenta blood cord amniotic fluid
a study to evaluate the safety, tolerability and the effects of ixodes ricinus-contact phase inhibitor (ir-cpi) in adult patients with spontaneous intracerebral haemorrhage

Conditions: Intracerebral Hemorrhage

Summary: the purpose of the study is to provide a first assessment of safety, tolerability and efficacy of ir-cpi, administered on top of standard-of-care, on secondary brain injury in patients with spontaneous intracerebral haemorrhage.


Eligibility criteria:
inclusion criteria: * male or female patients aged ≥ 18 years. * written informed consent obtained before any study assessment. if the patient is not able to give the informed consent personally, consent by a legal representative as defined by local law and regulation is acceptable. * first-ever, spontaneous, supratentorial intracerebral haemorrhage in cerebral cortex or deep brain structures (putamen, thalamus, caudate, and associated deep white matter tracts) with a volume ≥ 5 ml and ≤ 60 ml determined by non-contrast ct scan. * patients with glasgow coma scale (gcs) best motor score no less than 5. * modified rankin scale (mrs) score 0-2 prior to ich symptom onset. exclusion criteria: * history of personal or familial bleeding disorders; including prolonged or unusual bleeding. * known deficiency in factor xii (fxii) or haemophilia type a (fvii) or type b (fix) or type c (fxi). * infratentorial (midbrain, pons, medulla, or cerebellum) ich. * secondary ich due to aneurysm, brain tumour, arteriovenous malformation, thrombocytopenia, coagulopathy, acute sepsis, traumatic brain injury (tbi), or disseminated intravascular coagulation (dic). * planned neurosurgical hematoma evacuation or other urgent surgical intervention (i.e., surgical relief of increased intracranial pressure) on initial presentation. * anticoagulation reversal treatment. * patients with intraventricular haemorrhage (ivh) having a graeb score of \>3 on initial presentation. patients must not have blood in the 4th ventricle and may only have blood in the 3rd ventricle in the absence of ventricular expansion. trace or mild haemorrhage in either or both lateral ventricles is permitted. patients with hydrocephalus determined radiologically on initial presentation are excluded regardless of graeb score. * use of immunosuppressive or immune-modulating therapy at admission (e.g., steroids, methotrexate, monoclonal antibodies, etc). * patients with active systemic bacterial, viral or fungal infections. * women of childbearing potential. * have a body weight \> 120 kg at screening. * severe renal impairment (egfr \< 30 ml/min/1.73 m2).

Keywords: ir-cpi ich secondary brain injury ixodes ricinus-contact phase inhibitor neutrophil antithrombotic intracranial hemorrhage stroke brain inflammation neuroinflammation cerebrovascular disorders
randomized evaluation of treosulfan versus melphalan conditioning followed by ptcy in patients with aml and mds undergoing allogeneic transplantation

Conditions: AML - Acute Myeloid Leukemia; MDS (Myelodysplastic Syndrome)

Summary: the aim of this study is to compare the effectiveness and tolerability of two conditioning chemotherapies prior to allogeneic stem cell transplantation. the following will also be investigated: * survival * remission and relapse rate * engraftment or graft failure * graft versus host disease (gvhd)


Eligibility criteria:
main inclusion criteria: 1. informed consent signed by the patient capable of giving 2. patient scheduled for allogeneic transplantation within the next 3 weeks 3. age ≥ 18 years 4. aml or mds according to who with indication for allogeneic hct: 1. aml in first or second complete remission (cr) or complete remission with incomplete hematologic recovery (cri/crh) or morphologic leukemia-free state (mlfs) 2. mds according to who 5. increased risk for treatment-related toxicity by myeloablative conditioning according to at least one of the following criteria: 1. patients aged ≥ 50 years at transplant and/or 2. hct-ci \> 2 and/or 3. aml or mds scheduled for 2nd allogeneic hct from different donor with minimum of 12 months after 1st allogeneic hct 6. availability of a suitable donor: 1. matched sibling donor (msd) or 2. matched unrelated donor (mud, 10/10 hla) or 3. mismatched unrelated donor (mmud, single allele or antigen mismatch at hla-a, -b, -c, or -drb1 and no concurrent -dqb1 mismatch (9/10) shown by confirmatory typing) or 4. haploidentical family donor 7. planned gvhd prophylaxis with standard ptcy (with 50mg/kg body weight on days +3 and +4) 8. no history of cardiac disease that preclude allogeneic hct and absence of active symptoms, otherwise, documented left ventricular ejection fraction * 40 %. 9. no need for supplementary oxygen on day of randomization main exclusion criteria: 1. patients with acute promyelocytic leukemia with t(15;17)(q22;q12) 2. patients with graft failure after previous allogeneic hct 3. patients with scheduled 2nd allogeneic hct within 12 months after 1st allogeneic hct 4. pretreatment with either melphalan or treosulfan within the last 12 months prior to randomization 5. planned tbi as part of conditioning 6. severe organ dysfunction defined by either one of the following criteria: 1. serum bilirubin \> 1.5 × uln (if not considered gilbert-syndrome) or 2. alat or asat \> 5 × uln 7. uncontrolled infection at the time of randomization. 8. active viral hepatitis unless serology demonstrates clearance of infection. occult or prior hepatitis b virus (hbv) infection, defined as negative hepatitis b surface antigen and positive total hepatitis core antibodies, may be included if hbv dna is undetectable, provided that patients are willing to undergo monthly dna testing. patients who have protective titers of hepatitis b surface antibody after vaccination or prior cured hepatitis b are eligible. patients for hepatitis c virus (hcv) antibody are eligible provided pcr if negative for hcv rna. 9. pregnant or breastfeeding women
the effectiveness of double incision technique in uterus preserving surgery for placenta percreta

Conditions: Placenta Percreta

Summary: placenta percreta is a life-threatening condition that patients are under risk of massive bleeding. it readily necessitates very complicated surgery even leads to mortality. cesarean hysterectomy is the procedure that is acknowledged worldwide, however, recent studies discussing conservative treatment with segmental resections were published. fetal extraction and segmental resection could be performed from same (single uterine incision) or two different (double uterine incision) incisions. in this study, the investigators aimed to evaluate the effectiveness and the results of double uterine incision.


Eligibility criteria:
inclusion criteria: * intraoperatively and pathologically confirmed diagnosis of placenta percreta exclusion criteria: -

Keywords: efficacy double incision technique uterus preserving surgery
safety and efficacy of cem-102 with rifampin compared to standard therapy in patients with prosthetic joint infections or spacer infection

Conditions: Prosthetic Joint Infections of Hip; Prosthetic Joint Infections of Knee; Infected Spacers

Summary: to determine if oral antibiotic treatment with cem-102 and rifampin is as effective and safe as the standard of care antibiotic therapy for the treatment of hip and knee prosthetic joint or spacer infections


Eligibility criteria:
inclusion criteria: * prosthetic knee or hip joint infection * infected joint spacer * able to swallow tablets * able to voluntarily sign the informed consent form * females of childbearing potential must use an acceptable method of birth control * the joint infection must be attributed to bacterial pathogens sensitive to fusidic acid and rifampin exclusion criteria: * history of hypersensitivity or intolerability to sodium fusidate (fucidin®), or to rifampin * females who are pregnant or lactating * requirement for significant immunosuppression * bacteremia * known cirrhosis or decompensated liver disease * current treatment for hiv or hepatitis c * seizure disorder, requiring anti-convulsants

Keywords: prosthetic joint infection hip arthroplasty mrsa knee arthroplasty